In Amgen v. Apotex, the Federal Circuit held that under the Biologics Price Competition and Innovation Act (“BPCIA”), “an applicant must provide a reference product sponsor with 180 days’ post-licensure notice before commercial marketing begins.” The court dismissed concerns that its holding would extend the originator’s 12-year exclusivity period by 6 months, reasoning that the FDA could signal approval of a biosimilar before the 12-year exclusivity period has run, but is that correct?
In an en banc decision issued in The Medicines Company v. Hospira, Inc., the Federal Circuit determined that in order for a commercial transaction to trigger the on-sale bar of § 35 USC 102(b), it must “bear the general hallmarks of a sale pursuant to Section 2-106 of the Uniform Commercial Code.” Unlike the three-judge panel who first decided the case in July 2015, the full court determined that the contract manufacturing transaction for commercial quantities of Angiomax® did not rise to that level, and so affirmed the district court’s holding that it did not trigger the on-sale bar.
On July 14, 2016, the USPTO issued a Memorandum to the Patent Examining Corps on patent eligibility in view of recent court decisions. The July 2016 Memorandum extracts more guidance for assessing patent eligibility from the Federal Circuit decision in CellzDirect, and notes that the Supreme decision denying certiorari in Sequenom “does not elevate” the significance of the panel decision in that case. Continue reading this entry
In a complaint filed June 14, 2016, Janssen Biotech Inc. seeks a preliminary injunction that would bar Celltrion and Hospira from selling the biosimilar version of Remicade® (infliximab) that received FDA approval April 2016, and also could impact the production of the Celltrion/Hospira products sold abroad. This complaint is separate from the pending biosimilar litigation and based on alleged actual infringement of a patent directed to specific cell culture media compositions used to produce infliximab.
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Although the 12-year exclusivity period for original biologic products was a heavily negotiated provision of the Biologics Price Competition and Innovation Act (BPCIA), increased spending on biologic drugs has led to calls to shorten that exclusivity period to expedite biosimilar market entry. Most recently, on June 23, 2016, Illinois Congresswoman Jan Schakowsky and Senators John McCain (R-AZ) and Sherrod Brown (D-OH) introduced the “Price Relief, Innovation, and Competition for Essential Drugs” (PRICED) Act in the U.S. House of Representatives and Senate. The bills would amend the “first licensure” provisions of the BPCIA to shorten the market exclusivity period for new biologics from 12 to 7 years. Similarly, the President’s budget for fiscal year 2017 recommended “prohibiting additional periods of exclusivity for brand biologics due to minor changes in product formulations.”